Prescribing the Right Course of Action: Pharmacy Ethics in a Pandemic

Webinar for the Canadian Society of Hospital PharmacistsMay 7, 2020

Alison Thompson, PhDAssociate Professor

LEARNING OBJECTIVES

Identify the ethical issues in pharmacy practice during an

outbreak

Explore how ethical frameworks can help guide decision-making

during a pandemic

Develop process for moral discernment using some cases

from practice

Identify ethics resources for supporting professional practice

WHY ETHICS?

•Need a moral compass to guide difficultdecisions that will have to be made in thecontext of a pandemic

TWO WAYS FOR ETHICS TO CONTRIBUTE

Decision–making for and during a pandemic ought to be:

1) guided by ethical decision-making processes, &

2) informed by ethical values.

PHARMACY ETHICS ISSUES IN A PANDEMIC

Duty to Care

• Given our Chief PHO’s recent statement about non-medical grade masks being potentially beneficial to protect others, should pharmacists be wearing masks at all times?

Priority Setting

• Should pharmacists be rationing services in anticipation of a heightened demand for services or drug shortages (with the “next wave” of sickness)?

Standards of Care in a pandemic

• Should pharmacists be providing the same level of care to ALL patients, regardless of specific precautions in place? For example, how do we justify direction for pharmacy staff to limit usual direct contact with patients for purposes like BPMH and discharge medication education (see recent memo from ISMP)?

Use of unregistered agents or off-label use of medications

to treat COVID-19

• Are pharmacists compelled to offer any potentially beneficial pharmacotherapy to COVID-positive patients, especially those who are critically ill?

DUTY TO CARE: WHAT IS AT STAKE?

• Do HCWs have an obligation to treat patients despite risk of infection?

• What limits, if any, are there to health care workers’ duty to care?

• What institutional supports are owed to health care workers in a pandemic?

PRIORITY SETTING: WHAT’S AT STAKE?

• When should we implement rationing?

• Should priority be given to the sickest patients or those most likely to survive?

• Should resources be allocated to save the most lives or to give everyone a fair chance at survival?

• What is the role of the pharmacist in dispensing medications fairly when there are competing claims?

• Who should make these allocation decisions?

STANDARDS OF CARE IN A PANDEMICBeneficence

• Maintain highest quality of safe and effective care within resource/pandemic constraints by: • Ensuring standard of care and best practices whenever possible • Minimizing pain and suffering of individuals • Using alternative drugs or treatments where evidence suggests similar clinical

efficacy • Informing and educating health providers about benefits, risks and

appropriate use of alternative treatments, including risk mitigation strategies • Enabling individuals to receive care in the most appropriate setting • Monitor and evaluate outcomes when deviation from standard practice

occurs

USE OF ALTERNATIVE MEDICATIONS WITH LITTLE OR UNCERTAIN EFFICACY AND SAFETY DATA?

• Use of best available evidence

• Risk/benefit ratios may be different for patients who are critically ill

• Informed consent (patient or SDM)

• Beneficence vs nonmaleficence: is informed consent enough?

• Provision in the context of research preferable

• Ensure not contributing to drug shortages for patients who are benefiting from medication for proven clinical indications

• Ensure equity of access

RESOURCES FOR ETHICAL GUIDANCE

ETHICAL GUIDE FOR PANDEMIC RESPONSE:Thompson, A.K., Faith, K., Gibson, J.L. Et al. Pandemic influenza preparedness: an ethical framework to guide decision-making. BMC med ethics 7, 12 (2006). https://doi.Org/10.1186/1472-6939-7-12

10 substantive values:• Individual liberty

• Protection of the public from harm

• Proportionality

• Privacy

• Equity

• Duty to provide care

• Reciprocity

• Trust

• Solidarity

• Stewardship

5 Procedural Values:

• Reasonable

• Open and transparent

• Inclusive

• Responsive

• Accountable

DRUG SHORTAGES ETHICAL FRAMEWORK: OVERARCHING PRINCIPLESHTTP://WWW.HEALTH.GOV.ON.CA/EN/PRO/PROGRAMS/DRUGS/SUPPLY/DOCS/ETHICAL_FRAMEWORK.PDF

Beneficence - Maintain highest quality of safe and effective care within resource constraints

Solidarity - Build, preserve and strengthen inter-professional, inter-institutional, inter-sectoral, and inter- provincial/territorial collaborations and partnerships

Utility - Maximize the greatest possible good for the greatest possible number of individuals by: • Distributing drugs in short supply to those in most need and most likely to benefit

Equity - Promote just/fair access to resources• Ensuring burdens are not borne disproportionately by any patient, patient group, health sector, or institution • Using allocation processes for distribution of drugs and modification of services that do not arbitrarily disadvantage any particular patient, patient group,

health sector, or institution • Not discriminating between patients based on factors not relevant to their clinical situation (e.g., social status)

Stewardship - Use available resources carefully and responsibly• Postponing elective procedures/treatments that require use of drugs that are in limited supply • Prioritizing access to scarce drugs based on urgency and severity of need • Monitoring drug utilization and distribution to facilitate mid-course corrections as needed

Trust - Foster and maintain public, patient, and health care provider confidence in health system • Communicating in a clear and timely fashion • Making decisions in an open, inclusive and transparent way with clearly defined decision-making authority and accountability at all levels

ONTARIO DRUG SHORTAGES ETHICAL FRAMEWORK: ALLOCATION PRINCIPLESHTTP://WWW.HEALTH.GOV.ON.CA/EN/PRO/PROGRAMS/DRUGS/SUPPLY/DOCS/ETHICAL_FRAMEWORK.PDF

Stage 1:

risk of shortage

Implement strategies to preserve standard of care and best practices to the greatest extent possible within available drug supply:

Stage 2:

drug(s) in short supply

Apply primary allocation principles to optimize therapeutic benefit

Stage 3:

decisions must be made between patients within a level of priority

Apply secondary allocation principles to ensure fair access to needed care:

QUESTIONS?